NDC 35356-062-05 HUMAN PRESCRIPTION DRUG

Drug Status:  Deprecated

Proprietary Name: Fentanyl

Drug Overview

The NDC Code 35356-062-05 is assigned to “Fentanyl ” (also known as: “Fentanyl”), a human prescription drug labeled by “Lake Erie Medical DBA Quality Care Products LLC”. The product's dosage form is patch, and is administered via transdermal form.

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Drug Information
NDC Package Code	35356-062-05
	The labeler code, product code, and package code segments of the National Drug Code number, separated by hyphens. Asterisks are no longer used or included within the product and package code segments to indicate certain configurations of the NDC.
Product NDC	35356-062
	The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
11 Digit NDC Code	35356-0062-05
	It should be noted that many NDCs are displayed on drug packaging in a 10-digit format. Proper billing of an NDC requires an 11-digit number in a 5-4-2 format. Converting NDCs from a 10-digit to 11-digit format requires a strategically placed zero, dependent upon the 10-digit format.
Proprietary Name	Fentanyl
	Also known as the trade name. It is the name of the product chosen by the labeler.
Non Proprietary Name	Fentanyl
	Sometimes called the generic name, this is usually the active ingredient(s) of the product.
Product Type Name	HUMAN PRESCRIPTION DRUG
	Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
Labeler Name	Lake Erie Medical DBA Quality Care Products LLC
	Name of Company corresponding to the labeler code segment of the ProductNDC.
Status	Deprecated
	Possible status values: Active Active NDC Code Deprecated Deprecated NDC Code Unfinished (Unapproved) The following status describes submitted unfinished drugs, including the marketing categories of Active Pharmaceutical Ingredient (API), Drug for Further Processing, Bulk for Human Drug Compounding, and Bulk for Animal Drug Compounding. FDA does not review and approve unfinished products. Therefore, all products having "unfinished" status are considered unapproved.
DEA Schedule	CII — Schedule II (CII) Substance
	Schedule II (CII) Substance The controlled substances in this schedule have a high abuse potential with severe psychological or physical dependence liability, but have accepted medical use in the United States (US). CII controlled substances consist of certain narcotic, stimulant, and depressant drugs. Some examples of CII narcotics are: opium, morphine, codeine, hydromorphone (Dilaudid), methadone, meperidine (Demerol), cocaine, oxycodone (Percodan), anileridine (Lertine), the immediate precursor phenylacetone (P - 2 - P), and oxymorphine (Numorphan).Also in CII are the stimulants amphetamine (Dexedrine), methamphetamine (Desoxyn), phenmetrazine (Preludine), and methylphenidate (Ritalin); the depressants amobarbital, pentobarbital, secobarbital; and fentanyl (Sublimaze), etorphine hydrochloride, and phencyclidine (PCP). Schedules of Controlled Substances This is the assigned DEA Schedule number as reported by the labeler. Values are CI, CII, CIII, CIV, and CV. The CSA places each controlled substance—drug or other substance—into one of five schedules based on the substance’s medical use, potential for abuse, and safety or dependence liability. The Act also allows substance to be added to or removed from a schedule, and to be rescheduled or transferred from one schedule to another. The basis upon which substances are placed into each of the five schedules is explained below, and examples of drugs’ or other substances within the schedules are listed.
Description	Fentanyl transdermal system is a transdermal system containing fentanyl. The chemical name is N-Phenyl-N-(1-(2-phenylethyl)-4-piperidinyl) propanamide. The structural formula is. The molecular weight of fentanyl base is 336.5, and the molecular formula is C22H28N2O. The n-octanol:water partition coefficient is 860:1. The pKa is 8.4. System Components and Structure. The amount of fentanyl released from each system per hour is proportional to the surface area (25 mcg/hr per 6.25 cm2). The composition per unit area of all system sizes is identical. Fentanyl transdermal system is a transparent rectangular patch with rounded corners comprising a protective liner and two functional layers. Proceeding from the outer surface toward the surface adhering to skin, these layers are. 1) a backing layer of polyolefin film; 2) a drug-in-adhesive layer. Before use, a protective liner covering the adhesive layer is removed and discarded. Fentanyl transdermal systems are packaged with additional pieces of protective film above and below the system within each pouch. These are discarded at the time of use.
	General information about the drug product, including the proprietary and established name of the drug, the type of dosage form and route of administration to which the label applies, qualitative and quantitative ingredient information, the pharmacologic or therapeutic class of the drug, and the chemical name and structural formula of the drug.
Indication And Usage	Fentanyl transdermal system is a transdermal formulation of fentanyl indicated for the management of persistent, moderate to severe chronic pain in opioid-tolerant patients 2 years of age and older when a continuous, around-the-clock opioid analgesic is required for an extended period of time, and the patient cannot be managed by other means such as non-steroidal analgesics, opioid combination products, or immediate-release opioids. Patients considered opioid-tolerant are those who are taking at least 60 mg of morphine daily, or at least 30 mg of oral oxycodone daily, or at least 8 mg of oral hydromorphone daily, or an equianalgesic dose of another opioid for a week or longer.
	A statement of each of the drug productÕs indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition.This field may also describe any relevant limitations of use.

Route & Dosage
Dosage Form Name	PATCH
	The translation of the DosageForm Code submitted by the firm. The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.
Route Name	TRANSDERMAL
	The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
Pharmaceutical Classes	FULL OPIOID AGONISTS [MOA],OPIOID AGONIST [EPC]
	These are the reported pharmaceutical class categories corresponding to the SubstanceNames listed above.

Substance & Strength
Substance Name	FENTANYL - 12 ug/h
	This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

Drug Package Information
NDC Package Code	35356-062-05
	The labeler code, product code, and package code segments of the National Drug Code number, separated by hyphens. Asterisks are no longer used or included within the product and package code segments to indicate certain configurations of the NDC.
Package Description	5 PATCH IN 1 CARTON (35356-062-05) > 72 H IN 1 PATCH
	A description of the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. For example: 4 BOTTLES in 1 CARTON/100 TABLETS in 1 BOTTLE.
Sample Package	N
	Defines whether given package serves sample purposes.
Package NDC Exclude Flag	N
	This indicates whether the package has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions.
Package Start Marketing Date	20130109
	This is the date that the labeler indicates was the start of its marketing of the drug package.
Package End Marketing Date	N/S (NOT SPECIFIED)
	This is the date the package will no longer be available on the market. If a package is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Packages that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Packages with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.

Product Application & Marketing Information
Product NDC	35356-062
	The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
Application Number	ANDA076258
	This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
Marketing Category Name	ANDA
	Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
Listing Record Certified Through	20201231
	This is the date when the listing record will expire if not updated or certified by the firm.
Product Marketing Start Date	20130109
	This is the date that the labeler indicates was the start of its marketing of the drug product.
Product Marketing End Date	N/S (NOT SPECIFIED)
	This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
Product NDC Exclude Flag	N
	This indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions.

Tracking Information
Last Update Date	2021-01-01
	The date that a record was last updated or changed.